QA Manager

QA Manager

Our client, an international pharmaceutical company specializing in neurology, ophthalmology and dermatology, opens the position of a Quality Control Manager.

Responsibilities

· Overall responsibility for development and implementation of the Quality Management System;
· Maintain and lead QMS processes;
· Provide expertize on quality and compliance, provide input and support for the local Quality Strategies;
· Leading QA issues at local and CIS level;
· Development of GDP activities through the affiliate activities;
· Follow and implement all quality compliance requirements, participate in Critical Action Committees;
· Maintenance, updating and concluding QAA with vendors (GxP)
· RU GMP-inspections process owner;
· Budget owner, rational planning of activities;
· Reporting at local and global levels (QPI, performance plans, implementation of Site Quality Plans);
· Management of 2 subordinates

Requirements

· 5 years’ experience working in the Quality Assurance field, experience working with international standards and practices (GxP processes);
· Bachelor of Science Degree in Engineering , Pharmaceutical, chemical technological education or equivalent;
· Deep expertise and knowledge of pharmaceutical local regulations in Russia regarding circulation of medical products and MD;
· People management background;
· Proven experience in development and implementation of QMS;
· Understanding of GMP, GDP, and ISO requirements and the mechanisms to influence, as well as, successful interactions with regulatory agencies;
· Fluent in Russian and English.

Comment

Note

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